The Effect of ASTARTE™; Lactobacillus Crispatus, Lactobacillus Rhamnosus, Lactobacillus Jenesii and Lactobacillus Gasseri on the Reduction of Risk Factors for Recurrent Urinary Tract Infection in Women
Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Investigate the effect of dietary supplements/probiotic ASTARTE™ ( L. crispatus, L. rhamnosus, L. jensenii, L. gasseri) on the microbiome composition in the intestine and vagina and thereby a reduction of risk factors for the development of rUTI during 6 months of intervention in women aged 18-40 years. This is measured by the incidence of symptomatic UTI.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: t
View:
• Women 18-40 years of age
• Recurrent UTI (2 times UTI within 6 months or \> 3 times UTI infection within one year).
• The subjects should be informed about the trial protocol.
• The subject must be able to follow the protocol, have provided voluntary consent and have signed the declaration of consent.
Locations
Other Locations
Denmark
Gastrounit, Copenhagen University Hospital Hvidovre
RECRUITING
Hvidovre
Contact Information
Primary
Andreas Petersen, DM. PhD
andreas.munk.petersen@regionh.dk
+4538626199
Backup
Khaled Ghathian, phd.stud.
khaled.saoud.ali.ghathian@regionh.dk
+38623205
Time Frame
Start Date: 2022-09-19
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 720
Treatments
Active_comparator: ASTARTE™ oral capsule
The capsule will contain a mixture of four probiotic strains with a combined potency of 5 x10\^9 (CFU)/capsule:~Lactobacillus crispatus LBV88, 2 x10\^9 CFU/g Lactobacillus rhamnosus LBV96, 2 x10\^9 CFU/g Lactobacillus gasseri LBV150N , 0.6 x10\^9 CFU/g Lactobacillus jensenii LBV116, 0.4 x10\^9 CFU/g Corn starch 79 mg, Magnesium salts of fatty acid 3 mg, Silicon dioxide 3 mg, Vegetal capsule size 1 DR white 75 mg, Fructooligosaccharides 30mg
Placebo_comparator: Placebo oral capsule
The placebo oral capsules is identical to the ASTARTE™ capsules and contains Corn starch 79 mg, Magnesium salts of fatty acid 3 mg, Silicon dioxide 3 mg, Vegetal capsule size 1 DR white 75 mg, Fructooligosaccharides 30mg
Related Therapeutic Areas
Sponsors
Leads: Hvidovre University Hospital